Ali B. Email & Phone Number

Lyon, Fr

Écully, Auvergne-Rhône-Alpes, France

Ensuring all GxP and Business Critical Systems are designed, implemented and maintained in a compliant manner in accordance with Regulatory expectations.Subject Matter Expert (SME) of the QV Module of Veeva tool (DigiQual)

Marcy L'Etoile - Lyon France

- Verification and Validation Activities for the internal tools ( Manufacturing - Quality Control- R&D Immuno Assays and Clinical Affairs) (GxP critical Non Product Softwares specific to the site including Excel spreadsheets )- Risk based approach (Good Automation and Manufacturing Practices - GAMP 5)- Data Integrity- GAMP 5 - 21 CFR Part 820 and 21 CFR Part 11- Internal Auditor - EMEA and BioFire Inter-sites collaborations and support

- Definition and deployment of validation strategy for complex softwares Tools (ERP, SAP, EDMS...)- GxP Assessment- Support staff during the project lifecycle- Change Requests technical approval- Training for URS writing- 21 CFR Part 11 assessment Achievements:- SAP Hana upgrade- Windows 10 Upgrade- TrackWise Optimization - MDM R&D - Critical and complex Spreadsheets- Monolot France

(+ In Different Companies)

Since 2008,my experience as a Validation consultant in the pharmaceutical industry lead me to command all the validation process, including GMP and 21 CFR Part 11 compliance, on different kind of computerized systems, such as SAP, TrackWise, Documentum and automated systems for production equipment.I did different projects, in French, English and Spanish for the following customers:AptarGroup,Sanofi Pasteur, GlaxoSmithKline,Novartis, Mérial, Merck Serono, Ipsen and Mylan France.

Marcy L'Étoile

• NuGenesis [ storage application of lab equipment data]o Review and update existing instructions (vs IS-edoc)o Manage the CAPA from the latest periodic reviewo Update the list of all the connected equipment to NuGenesis and the business data (manager, localization and status) and IS data (template, IS Docs ...)o Documentation and communication related to the new process (INIT) of NuGenesis connection • eBioBank [storage application for cells and strains into Nitrogen freezers]o update the documentations such as : SOPs , guidelines, requests forms (managed in e-room and ReD edoc)o update the list of users access vs training and freezerso impact analysis regarding the new naming convention of the biological material : data inventories to be modified , participate to the strains creation reviewo update the values into SAP and execute OQ tests• Tick@lab [system application managing the flows of lab animals experiences]o Participate to the writing and validation of URS, FS , tests scenarios, SOPs and guidelineso UAT documentation / execution

Région De Lyon, France

Supporting the Quality/ Validation tasks linked with the solutions maintenance activities (Validation Plan, Risk Analysis ,Traceability Matrix, Conformity Certificate)• Updating working instructions ( Change control, Access Management)• Managing the access to the different SAP Athena Environments• Supporting the Regional CCS during SAP Athena & SFM deployments and roll-ins.• Following up the SAP Athena and SFM releases , Validation documentation( Validation Plan,GxP Analysis, UAT Strategy , Traceability Matrix, Technical & Functional Analysis , VersionRelease Note, Release Change Control List …)

Worldwide

My position reports to the IS Compliance and Validation Manager.I am in charge of defining the Computerized Systems Validation strategy and approach for IS systems (such TrackWise) delivered to the Pharma - Beauty & Home - Food & Beverage - market segments of Aptar and also for the Aptar 1 SAP roll-ins in France, Germany, Switzerland, Italy, Spain, Colombia and North America plants and facilities.I am administrator of the Document Management System (DMS) : monitoring approval workflows, authorizations and reports for all the IS projects OF all Aptar Group segments in coordination with the IS and Business project managers and Functional Design Management (FDM) Coordinators.Also in charge to release the non GMP (Good Manifacturing Practices ) relevant Requests for Change (RFC) in Solution Manager System (SolMan) and in TrackWise systems.For the Aptar 1 SAP roll-ins , I am in charge to monitor the Master Data Migration and Validation / Approvals with the Master Data Migration Team ( MDM Leader , MDM FDM and Regional Key User ) - Trainings are provided to the FDM and Local / Regional Key Users ( Validation and Migration Methodologies )Main deliverables are : User Requirements Specifications (URS) , Functionnal Specifications (FS) , Validation Plan (VPL) , Installation Qualification Protocol (IQP) , Operationnal Qualification Protocol (OQP) and test forms (OQTF), Performance Qualification Protocol (PQP) and Go Live Decision Report (GDR)

Région De Lyon, France

SAP Periodic Review

Master 2 (M2), Organizations Quality Management - Faculté De Pharmacie Lyon 1

Activities and Societies: Association des Qualiticiens de Lyon

Master International, Master 2 Management De La Qualité Et Sécurité Alimentaire

Bachelor'S Degree, Food Safety And Control

Master Gestion De La Calidad Y Seguridad Alimentaria